Metastatic MelanomaPhase 1NCT00527761
Taxotere/Temodar/Cisplatin Study in Melanoma Patients
A Phase 1 study testing Cisplatin, Docetaxel and Temodar in people with Metastatic Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma. Secondary Objectives: 1. To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Cisplatin, Docetaxel and Temodar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 or older with histologically documented diagnosis of advanced/inoperable melanoma are eligible.
- Patients must have measurable metastatic melanoma lesion(s), and at least 1 lesion must be greater then or equal 10 mm in a greatest diameter by spiral CT scan (or greater then or equal to 20 mm by a conventional non-spiral CT scan) to assess response. Cutaneous lesions may be 10 mm or larger in a greatest diameter.
- Patients with less than or equal to grade 1 peripheral neuropathy at the time of enrollment.
- Patients with controlled, asymptomatic brain metastases will be eligible. There should not be any evidence of progression in the brain metastases for at least 3 months after the complete surgical resection/stereotactic radiosurgery and/or a whole brain radiation therapy. Patients who are taking steroidal or anticonvulsant drug(s) for brain metastasis at the time of registration will not be eligible.
- Zubrod performance status of 0-2.
- ANC greater than or equal to 1,500/mm3 and a platelet count greater than or equal to 100,000/mm3.
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- Serum creatinine less than or equal to 1.5 mg/dl
- Serum bilirubin level of less than or equal to 1.0 mg/dl (or up to institutional upper limit of normal (ULN))
- Serum transaminase (ALT and AST) less than or equal to 125 IU/l (or up to 2.5 x institutional ULN) if alkaline phosphatase is less than or equal to 130 IU/l (or institutional ULN), or alkaline phosphatase less than or equal to 500 IU/l (or up to 4 x ULN) if transaminases are less than or equal to 50 IU/l (or institutional ULN).
- No evidence of significant cardiac or pulmonary dysfunction.
- Patient must have a hemoglobin greater than or equal to 9 gm/dl (this may be achieved by transfusion if needed) obtained within 14 days prior to registration. If a patient receives PRBC transfusion to achieve a hemoglobin level of greater than or equal to 9 gm/dl, the hemoglobin level needs to be stable (no drop by more than 1 gm/dl from the post-transfusion hemoglobin level) for at least 1 week.
- Women of childbearing potential must have a negative pregnancy test and may not be breastfeeding.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent for treatment and in accordance with institutional and federal guidelines.
Who cannot join
- A prior exposure to all 3 drugs: taxanes, Temodar and platinum.
- A history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
- Any anti-cancer therapy within 28 days prior to enrollment.
- If a target lesion has been previously embolized, perfused or irradiated, there must be objective evidence of progression before start of therapy to be considered for response assessment.
- Uncontrolled brain metastases. Patient who is symptomatic from brain metastases or who takes steroidal or anticonvulsant drug for the management of brain metastases will be ineligible. Central nervous system involvement by melanoma either as spinal cord compression or leptomeningeal disease will also be excluded.
- Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF less than 55%) on account of any organic disease such as hypertension or valvular heart disease or serious uncontrolled cardiac arrhythmias despite therapy.
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- Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity or FEV1 to less than 75% of predicted normal values.
- Symptomatic effusions on account of pleural, pericardial or peritoneal metastasis of melanoma.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least for 5 years), or any other cancer from which the patient has been disease-free for 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Study of TTC (Taxotere/Temodar/Cisplatin) in Metastatic Melanoma Patients
Primary Objective:
- To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.
Secondary Objectives:
- To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma
- To determine the response rate of induction chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.
Read the detailed description
Temozolomide, docetaxel, and cisplatin are "chemotherapy" drugs, known to kill tumor cells by interfering with the important structures in these cells to grow and divide. Each of these drugs has been used separately for melanoma treatment. These 3 drugs have not been used in combination.
Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including routine blood tests (less than 3 tablespoons). You will have an electrocardiogram (EKG - test to measure the electrical activity of the heart), a chest x-ray, and CT scans of the chest and abdomen. You will have a MRI or CT scan of brain will as well. Depending on the location of melanoma, CT scans of the head and neck or pelvis and/or a bone scan may be taken. Photographs of the tumor may be taken if the tumors are located on the surface of the skin. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible, you will receive temozolomide, cisplatin, and docetaxel. The doses of temozolomide and cisplatin will be fixed for all groups. The dose of docetaxel will be changed between patient groups until the highest safe dose is found Between 3 and 6 patients will be enrolled in each group. Docetaxel will be given by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15). This will be followed by one week of rest. These 3 weeks of treatment and 1 week or rest make up 1 cycle. Cisplatin will be given by vein once a day for four days in a row (Days 1, 2, 3 and 4) over 2 hours each cycle. Temozolomide will be taken by mouth for five days in a row (Days 1, 2, 3, 4 and 5) of each cycle. The number of temozolomide pills that you take will be based on your height and weight. Temozolomide must be taken on an empty stomach (at least 2 hours before or after meals).
For your comfort in receiving cisplatin and docetaxel by vein, your doctor may recommend a catheter. A catheter is a plastic tube that is inserted into a vein in one of your arms or into the vein that runs underneath the collar bone, and then threaded into the central vein in the upper part of the chest.
The first dose of docetaxel and all of the cisplatin doses must be given at M.D. Anderson on an outpatient basis. All of the temozolomide doses can be taken at home and the Day 8 and Day 15 doses of docetaxel can be taken at a local clinic.
You may receive granulocyte colony-stimulating factor (G-CSF) to help the body produce new blood cells. G-CSF would be given as an injection under the skin on Days 9-13 of each cycle (except the first cycle).
During the study, you will have a complete physical exam every 4 weeks. Blood samples (1 tablespoon or less) will be taken weekly to monitor the blood counts and liver functions. A chest x-ray and CT scans of the chest and abdomen with or without head and neck and pelvis will be done every 2 cycles (8 weeks). A MRI or CT scan of the brain as well as photographs may also be taken every 2 cycles during the study. For patients who have significant tumor shrinkage with the treatment, these imaging studies may be repeated in 4 weeks.
All participants can receive at least 6 cycles of treatment. If your tumor continues to shrink after the end of 6 cycles, you may be eligible to receive further treatment at the discretion of the study chair. You may be taken off study early, if your disease gets worse or intolerable side effects occur.
You will have one last "follow-up" visit once you are taken off study. At this visit you will have a complete physical exam and blood samples (1 tablespoon) for routine tests will be taken. You will have a chest x-ray and CT scans of the chest and abdomen, with or without head and neck and pelvis, and with or without a MRI of brain at this visit as well.
This is an investigational study. The FDA has approved all of the drugs in this study, and they are commercially available. However, their use together in this study is experimental. Up to 30 patients will take part in this study. All will be enrolled at M.D. Anderson.
- Conditions
- Metastatic Melanoma
- Keywords
- Metastatic Melanoma, Temozolomide, Temodar, Taxotere, Cisplatin, TTC
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol-AQ, Platinol, CDDP
20 mg in 500 ml of normal saline by vein over 60 minutes daily for 4 days starting on day 1 of chemotherapy.
DocetaxelDrug
Also called Taxotere
Starting dose 20 mg by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15).
TemodarDrug
Also called Temozolomide
150 mg by mouth (PO) on Days 1 - 5.
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide, Docetaxel + Cisplatin | Experimental | Not described Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: Temodar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: 4 week cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startAug 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Kevin B. Kim, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527761
- Sponsor's protocol ID
- 2003-1037
- Status last verified
- Jul 2012
- First submitted
- 10 Sep 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of TTC (Taxotere/Temodar/Cisplatin) in Metastatic Melanoma Patients
- ClinicalTrials.gov ID
- NCT00527761
- Acronym / sponsor ID
- 2003-1037
- Conditions
- Metastatic Melanoma
- Keywords
- Metastatic Melanoma, Temozolomide, Temodar, Taxotere, Cisplatin, TTC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Aug 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.
Secondary Objectives:
- To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma
- To determine the response rate of induction chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.
Detailed description
Temozolomide, docetaxel, and cisplatin are "chemotherapy" drugs, known to kill tumor cells by interfering with the important structures in these cells to grow and divide. Each of these drugs has been used separately for melanoma treatment. These 3 drugs have not been used in combination.
Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including routine blood tests (less than 3 tablespoons). You will have an electrocardiogram (EKG - test to measure the electrical activity of the heart), a chest x-ray, and CT scans of the chest and abdomen. You will have a MRI or CT scan of brain will as well. Depending on the location of melanoma, CT scans of the head and neck or pelvis and/or a bone scan may be taken. Photographs of the tumor may be taken if the tumors are located on the surface of the skin. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible, you will receive temozolomide, cisplatin, and docetaxel. The doses of temozolomide and cisplatin will be fixed for all groups. The dose of docetaxel will be changed between patient groups until the highest safe dose is found Between 3 and 6 patients will be enrolled in each group. Docetaxel will be given by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15). This will be followed by one week of rest. These 3 weeks of treatment and 1 week or rest make up 1 cycle. Cisplatin will be given by vein once a day for four days in a row (Days 1, 2, 3 and 4) over 2 hours each cycle. Temozolomide will be taken by mouth for five days in a row (Days 1, 2, 3, 4 and 5) of each cycle. The number of temozolomide pills that you take will be based on your height and weight. Temozolomide must be taken on an empty stomach (at least 2 hours before or after meals).
For your comfort in receiving cisplatin and docetaxel by vein, your doctor may recommend a catheter. A catheter is a plastic tube that is inserted into a vein in one of your arms or into the vein that runs underneath the collar bone, and then threaded into the central vein in the upper part of the chest.
The first dose of docetaxel and all of the cisplatin doses must be given at M.D. Anderson on an outpatient basis. All of the temozolomide doses can be taken at home and the Day 8 and Day 15 doses of docetaxel can be taken at a local clinic.
You may receive granulocyte colony-stimulating factor (G-CSF) to help the body produce new blood cells. G-CSF would be given as an injection under the skin on Days 9-13 of each cycle (except the first cycle).
During the study, you will have a complete physical exam every 4 weeks. Blood samples (1 tablespoon or less) will be taken weekly to monitor the blood counts and liver functions. A chest x-ray and CT scans of the chest and abdomen with or without head and neck and pelvis will be done every 2 cycles (8 weeks). A MRI or CT scan of the brain as well as photographs may also be taken every 2 cycles during the study. For patients who have significant tumor shrinkage with the treatment, these imaging studies may be repeated in 4 weeks.
All participants can receive at least 6 cycles of treatment. If your tumor continues to shrink after the end of 6 cycles, you may be eligible to receive further treatment at the discretion of the study chair. You may be taken off study early, if your disease gets worse or intolerable side effects occur.
You will have one last "follow-up" visit once you are taken off study. At this visit you will have a complete physical exam and blood samples (1 tablespoon) for routine tests will be taken. You will have a chest x-ray and CT scans of the chest and abdomen, with or without head and neck and pelvis, and with or without a MRI of brain at this visit as well.
This is an investigational study. The FDA has approved all of the drugs in this study, and they are commercially available. However, their use together in this study is experimental. Up to 30 patients will take part in this study. All will be enrolled at M.D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temozolomide, Docetaxel + Cisplatin | Experimental | Drug: Cisplatin, Drug: Docetaxel, Drug: Temodar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients 18 or older with histologically documented diagnosis of advanced/inoperable melanoma are eligible.
- Patients must have measurable metastatic melanoma lesion(s), and at least 1 lesion must be greater then or equal 10 mm in a greatest diameter by spiral CT scan (or greater then or equal to 20 mm by a conventional non-spiral CT scan) to assess response. Cutaneous lesions may be 10 mm or larger in a greatest diameter.
- Patients with less than or equal to grade 1 peripheral neuropathy at the time of enrollment.
- Patients with controlled, asymptomatic brain metastases will be eligible. There should not be any evidence of progression in the brain metastases for at least 3 months after the complete surgical resection/stereotactic radiosurgery and/or a whole brain radiation therapy. Patients who are taking steroidal or anticonvulsant drug(s) for brain metastasis at the time of registration will not be eligible.
- Zubrod performance status of 0-2.
Key exclusion criteria (9 listed)
- A prior exposure to all 3 drugs: taxanes, Temodar and platinum.
- A history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
- Any anti-cancer therapy within 28 days prior to enrollment.
- If a target lesion has been previously embolized, perfused or irradiated, there must be objective evidence of progression before start of therapy to be considered for response assessment.
- Uncontrolled brain metastases. Patient who is symptomatic from brain metastases or who takes steroidal or anticonvulsant drug for the management of brain metastases will be ineligible. Central nervous system involvement by melanoma either as spinal cord compression or leptomeningeal disease will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: Platinol-AQ, Platinol, CDDP20 mg in 500 ml of normal saline by vein over 60 minutes daily for 4 days starting on day 1 of chemotherapy. | Drug | Temozolomide, Docetaxel + Cisplatin |
| DocetaxelAlso: TaxotereStarting dose 20 mg by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15). | Drug | Temozolomide, Docetaxel + Cisplatin |
| TemodarAlso: Temozolomide150 mg by mouth (PO) on Days 1 - 5. | Drug | Temozolomide, Docetaxel + Cisplatin |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 4 week cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin B. Kim, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cisplatin, Docetaxel and Temodar in people with Metastatic Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 4 week cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.